Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-04 @ 12:48 AM
Study NCT ID:
NCT02718950
Status:
UNKNOWN
Last Update Posted:
2016-03-24
First Post:
2016-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans', 'timeFrame': '2 weeks', 'description': 'Activation of BAT, as considered Standard Uptake Value (SUV) threshold of 2.0 on 18-FDG-PET CT, prior to liraglutide use and after 2 weeks on liraglutide 3.0 mg'}], 'secondaryOutcomes': [{'measure': 'Evaluate the effect of liraglutide administration on hypothalamic activation in humans', 'timeFrame': '2 weeks', 'description': 'Evaluate the effect of liraglutide administration on hypothalamic tract activation as assessed by magnetic resonance image in humans prior and after 2 weeks on liraglutide 3.0 mg'}, {'measure': 'Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans', 'timeFrame': '2 weeks', 'description': 'Evaluate the effect of liraglutide administration on non-shivering thermogenesis by infrared thermography and indirect calorimetry in humans prior and after 2 weeks on liraglutide 3.0 mg'}, {'measure': 'Evaluate the effect of liraglutide administration on body weight in humans', 'timeFrame': '2 weeks', 'description': 'Evaluate the effect of liraglutide administration on total body weight (kg) in humans prior and after 2 weeks on liraglutide 3.0 mg'}, {'measure': 'Evaluate the effect of liraglutide administration on metabolic basal rate in humans', 'timeFrame': '2 weeks', 'description': 'Evaluate the effect of liraglutide administration on basal kilocalories/day in humans prior and after 2 weeks on liraglutide 3.0 mg'}, {'measure': 'Evaluate the effect of liraglutide administration on body composition in humans', 'timeFrame': '2 weeks', 'description': 'Evaluate the effect of liraglutide administration on lean mass and fat percentage as assessed by dual x-ray absorptiometry (DXA) in humans prior and after 2 weeks on liraglutide 3.0 mg'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Brown Adipose Tissue', 'Hypothalamic Activation', 'Non-shivering Thermogenesis', 'Basal Metabolic Rate', 'Liraglutide', 'Victoza', 'Body Composition', 'Body weight', 'Adipose Tissue Biopsy'], 'conditions': ['Obesity', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index over 30 kg/m2.\n\nExclusion Criteria:\n\n* Hypersensitivity to liraglutide or any of its vehicle components;\n* History of diabetes or pre-diabetes - either by fasting glycemia, oGTT or HbA1c;\n* Previous treatment within the last 3 months with glucagon like peptide-1 agonists, iDPP4 or any medication that is associated with BAT activation, including propranolol and benzodiazepines;\n* Liver diseases, except non-alcoholic steatohepatitis (NASH);\n* Infection by HIV, hepatitis B or hepatitis C;\n* Addiction to cannabis, heroin, morphine, cocaine, benzodiazepines or amphetamine;\n* Obesity induced by other disorders such as Cushing syndrome, hypothyroidism, lipodystrophy\n* Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tricyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium);\n* Current participation (or within the last 3 months) in an organized weight reduction program\n* Currently or previous using within 3 months before screening of pramlintide, sibutramine, orlistat, topiramate, or metformin (either by prescription or as part of a clinical trial)\n* Participation in a clinical trial within the last 3 months prior to screening\n* Simultaneous participation in any other clinical trial of an investigational drug\n* Previous surgical treatment of obesity;\n* Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial\n* Liver enzyme (ALT and AST) above 2.5 x of reference range\n* Pancreatic enzymes (amylase, lipase) above 3 x the reference range\n* Chronic kidney disease stages 3, 4, or 5\n* Relevant inflammatory or acute or chronic infectious disease; hyperthyroidism; neurological, psychiatric, gastrointestinal, respiratory, renal, hepatic or cardiac relevant disease, that could interfere with trial results per the judgment of investigator\n* Any condition that at the discretion of investigator could interfere with treatment adhesion on patient safety\n* Blood donation or transfusion within the last 3 months\n* Pregnancy or intention of pregnancy\n* History of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)\n* History of pancreatitis\n* Less than 80% of liraglutide adherence\n* Calcitonin above the reference range at the screening visit."}, 'identificationModule': {'nctId': 'NCT02718950', 'acronym': 'i-LAB', 'briefTitle': 'Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans', 'orgStudyIdInfo': {'id': 'i-LAB'}, 'secondaryIdInfos': [{'id': 'U1111-1178-4180', 'type': 'REGISTRY', 'domain': 'Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide 3.0 mg', 'description': 'Subjects will use liraglutide 3.0 mg for 2 weeks.', 'interventionNames': ['Drug: Liraglutide 3.0 mg']}], 'interventions': [{'name': 'Liraglutide 3.0 mg', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'Subjects will use liraglutide 3.0 mg for 2 weeks', 'armGroupLabels': ['Liraglutide 3.0 mg']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bruno Geloneze, MD, PhD', 'role': 'CONTACT', 'email': 'bgeloneze@terra.com.br', 'phone': '+55 19 35218589'}], 'overallOfficials': [{'name': 'Bruno Geloneze, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas'}, {'name': 'Lício A Velloso, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas'}, {'name': 'José C Lima Júnior, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campinas'}, {'name': 'Riobaldo M Cintra, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campinas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Bruno Geloneze', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}